Back to resultsStudy Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
Primary Purpose
Uterine Leiomyomata (Fibroids)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRA-027
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Leiomyomata (Fibroids)
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria - All Women
- Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.
Inclusion Criteria - Cycling Women
- Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).
Inclusion Criteria - Postmenopausal Women
- Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.
Exclusion Criteria:
- Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
- History of drug abuse (within 6 months) or alcoholism (within 12 months).
- History of female infertility.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
Secondary Outcome Measures
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.
Full Information
NCT ID
NCT00543790
First Posted
October 11, 2007
Last Updated
October 27, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00543790
Brief Title
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyomata (Fibroids)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRA-027
Intervention Description
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.
Time Frame
28 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria - All Women
Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.
Inclusion Criteria - Cycling Women
Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).
Inclusion Criteria - Postmenopausal Women
Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.
Exclusion Criteria:
Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
History of drug abuse (within 6 months) or alcoholism (within 12 months).
History of female infertility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3208A1-1001&StudyName=Study%20Evaluating%20PRA-027%20Multiple%20Ascending%20Doses%20In%20Cycling%20And%20Postmenopausal%20Women
Description
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Learn more about this trial
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
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